Work

Verification of the analytical performance of the Human thyroid stimulating hormone assay on ALINITY ci ® Experience from the biochemistry laboratory of Mohammed VI University Hospital in Oujda

Year: 2025

Type: article

Abstract: The aim of our work was to evaluate the analytical performance of the Human Thyroid Stimulating Hormone (TSH) determination by a two-step immunoassay using microparticle chemiluminescence immunoassay (CMIA) technology, in accordance with the Scope A criteria of the guide of the verification/validation of medical biology methods. We evaluated the repeatability and the intermediate precision of the assay. The results obtained are very satisfactory for the three levels (low, medium and high), both for intermediate fidelity, with coefficients of variation (CV) of 5.38%, 4.16%, and 5.81%. Respectively, and for repeatability, with coefficients of variation of CV1 = 2.17%, CV2 = 1.54%, CV3 = 1.98% respectively. The results obtained made it possible to verify the method's performance and compare it with the analytical objectives set in order to meet the regulatory and normative requirements set by the supplier and learned societies.

Source: World Journal of Biology Pharmacy and Health Sciences

DOI: 10.30574/wjbphs.2025.21.3.0499

Authors: KIDOUN Asmae, KRIMI Kholoud, DOUICHI Imane, El Moujtahide Dounia, El Houcine Sebbar, Mohammed Choukri

Institutions: Mohamed I University, Centre Hospitalo-Universitaire Mohammed VI d'Oujda

Language: English

Topic: Clinical Laboratory Practices and Quality Control

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W4408851426